Tigecycline is an antibiotic with a broad spectrum of antibacterial activity. Importantly tigecycline is effective against several resistant strains of bacteria. Tigecycline in a powder presentation is reconstituted by the addition of a compatible reconstitution diluent prior to intravenous infusion. The antibiotic tigecycline is a t-butylglycyl substituted naphthacenecarboxamide free base.
Tigecycline is however difficult to manufacture because it is vulnerable to degradation including oxidative degradation from atmospheric oxygen and epimer formation.
There is therefore a need for a manufacturing process which controls epimerization and oxidation of tigecycline in bulk manufacturing.